China simplifying process for efficiency

Stewart Eisenhart, of Massdevice.com, reported that the China Food & Drug Administration (CFDA) is moving forward with improvements to their classification of medical devices process and is simplifying the road to the market for innovative devices. China has a three point plan to finish this project. First, create an online medium for medical device manufacturers to request regulatory validation of their product classification if they are unsure of its classification. In the past, it was purely a written process. Second, there will now be exemptions to the China Compulsory Certification (CCC) Mark certification that applies more to automotive, wireless, and consumer products. There will be only eight categories that will be exempt from the CCC. Finally, according to China Briefing, a new approval process can push new innovative devices into the market much quicker by having special circumstances and priority status to the review board. Will China be at risk with a less stringent path to market for innovative devices? Read the full article here.

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